Kornimate/medical-research-clean huggingface dataset:
a study of plx3397 in patients with unresectable or metastatic kit-mutated melanoma

Conditions: Melanoma

Summary: the purpose of this phase i/ii study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug plx3397 in subjects with unresectable or metastatic kit-mutated melanoma.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * unresectable stage iii or stage iv melanoma which is histologically confirmed at the treating institution with kit mutation(s) not known to be resistant to plx3397 * presence of measurable lesions by response evaluation criteria in solid tumors * eastern cooperative oncology group (ecog) performance status (ps) 0-2 * life expectancy ≥ 3 months * adequate organ and bone marrow function * women of child-bearing potential must have a negative serum pregnancy test at screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile. * fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug. * willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements exclusion criteria: * prior treatment with a kit inhibitor for melanoma * presence of nras or braf mutation * exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy * symptomatic brain metastases. * active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the sponsor * concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable) * uncontrolled intercurrent or infectious illness * major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study * previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry * inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption * congestive heart failure (chf) new york (ny) heart association class iii or iv; unstable coronary artery disease \[myocardial infarction (mi) more than 6 months prior to study entry is permitted\] or serious cardiac arrhythmia * baseline qt interval corrected using fridericia equation (qtcf) ≥ 450 msec (for males) or ≥ 470 msec (for females) at screening * active or chronic infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis b virus (hbv) * known chronic liver disease * women who are breast-feeding or pregnant

Keywords: plx3397 kit-mutant melanoma unresectable or metastatic kit-mutated melanoma developmental phase i/ii
evaluation of systemic atherothrombosis in patients with arterial disease of the lower limbs

Conditions: Peripheral Arterial Disease; Carotid Stenosis; Abdominal Aortic Aneurysm

Summary: the purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of pad, for asymptomatic carotid stenosis and abdominal aortic aneurysm.

the evart study is a prospective epidemiological multicenter cohort study, including patients with newly diagnosed pad (\< 1 year). initial data on medical history, caracterisation of the pad (risk factors, main sites and severity of the atherosclerotic lesions),clinical evaluation of undetected previous cv events, standardized us duplex examination of the abdominal aorta and carotid arteries and treatment (type and duration) are collected by the physician into an electronic medical record. a phone follow up at 3 months, 1, 2 and 3 years is realised by the centre for clinical research of grenoble. data on mortality, revascularization, treatments prescribed (type and duration), cancer onset, cardiovascular events, carotid stenosis, abdominal aortic aneurysm are collected. all these serious adverse events are documented and reviewed by an independent critical events committee.

Eligibility criteria:
inclusion criteria: * patient with newly diagnosed pad \< 1 year * symptomatic or asymptomatic : abi\ 1.30 exclusion criteria: * history of previous coronory or cerebrovascular event * previous investigation of the aorta and cervical arteries * prisoners * subjets with no affiliation to the social security system or equivalent

Keywords: lower limbs arterial diseases
blue blockers at night and insomnia symptoms

Conditions: Insomnia; Sleep

Summary: under entrained conditions, humans maintain a consolidated nocturnal sleep episode that coincides with environmental darkness and endogenous melatonin secretion. various factors, such as artificial light, can compromise this temporal harmony, resulting in sleep disruption. light is the strongest synchronizer of the circadian clock, with direct inputs via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms. evening light exposure can suppress melatonin secretion and worsen sleep. this is critical, since most individuals routinely expose themselves to light before bedtime. the high sensitivity of the circadian system to blue wavelength light indicates that modern light sources such as light-emitting diodes (led) may have particularly deleterious effects on sleep. it is possible to selectively filter out blue light while maintaining other visible spectra with blue-blocking (bb) lenses. wearing bb lenses before bedtime may present a simple, affordable, and safe method to improve sleep. none have yet investigated the effects of bb lenses on subjective and objective sleep in insomnia patients, while simultaneously exploring the effects on melatonin secretion.

this study seeks to investigate the impact of bb lenses on melatonin and sleep in insomnia patients using a randomized, placebo-controlled crossover study, with the aim of developing a novel non-pharmacological approach for the treatment of insomnia. 15 individuals with insomnia will wear either bb or placebo (clear) lenses for 2 hours preceding bedtime while at home, for 1 week in a cross-over design. sleep quality will be documented while at home, at also melatonin secretion while in the laboratory. it is predicted that compared to placebo, wearing bb lenses for 2 hours preceding bedtime will attenuate bright light associated melatonin suppression and improve sleep.

Eligibility criteria:
inclusion criteria: * insomnia for at least 1 month based on insomnia symptoms questionnaire exclusion criteria: * obstructive sleep apnea; narcolepsy; periodic leg movement disorder * currently shift worker * psychiatric or neurologic disorders * deep vein thrombosis * current cigarette smoker * currently taking beta-blockers * pregnant/breastfeeding * children less than 1 year old at home * excessive daily caffeine intake
acupuncture and insulin doses in insulin-treated type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is a randomized, single blinded, cross-over interventional study for evaluating the effect of acupuncture versus sham acupuncture in diabetic type 2 patient in insulin treatment. primary end-point of the study is the difference of daily units of insulin between treatment and control group; secondary end point are the variation of glycated hemoglobin levels, lipids panel (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides), c reactive protein and adiponectin. variation of epicardial fat thickness will be also evaluated by echography. acupuncture and sham treatment will be administered twice a week for 3 months and, after a pause of one month and cross-over between groups for other three months. acupuncture treatment will include use of somatic points (sp6; st36; ki3; cv4; cv12; te5; li4; li11; yintang; st28; bl23; bl22; bl20; bl13) and auricular points (most tender point on palpation with pressure feelers of 400 g on stomach, endocrine, spleen, kidney, hungry, shen man and pancreas auricular points). sham acupuncture will be applied distal from acupuncture points and areas used for treatment, with shallow insertion and without manipulation of the needle (15 needles in total on thorax, abdomen, back, arms and legs).


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * insulin therapy \> 20 ui daily for at least 6 months * hba1c \< 69 mmol/mol exclusion criteria: * class i psychiatric illness not adequately treated * actual pregnancy or breastfeeding, or pregnancy planning. * corticosteroid treatment * severe heart failure (nyha iii-iv) * severe renal failure (pre-dialysis o dialysis), * severe liver insufficiency (overt cirrhosis) * severe respiratory failure (oxygen therapy)

Keywords: acupuncture insulin sensitivity
study of bevacizumab and erlotinib in patients with advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.

there is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. with the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. this is an important population that needs less toxic therapies.

Eligibility criteria:
inclusion criteria: * cytologically or histologic confirmed non-small cell lung cancer, stage iiib or iv or recurrent after primary surgery or radiotherapy. * ecog ps 0-1 * 70 years of age or older * must have measurable disease * anc \> 1500, platelets \> 100,000 * total bilirubin \</= 1.5, sgot \* sgpt \< 5 x uln * able and willing to swallow and absorb oral medication * able and willing to sign consent * request archival diagnostic tissue for egfr expression but not required exclusion criteria: * proteinuria as demonstrated by upc ratio \>/= 1.0 * prior treatment with an investigational or marketed inhibitor of the egfr pathway or anti-angiogenesis agent (includes thalidomide) * prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic) * history of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation * evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment. * current, ongoing treatment with full dose warfarin or equivalent * current(within 10 days)use of aspirin (\> 325mg/day) or other nsaid with antiplatelet activity * history of hemorrhagic or thrombotic stoke, tia, or other cns bleeding w/in last 6 months. clinically significant pvd * known cns disease except for treated brain mets. * squamous cell histology * blood pressure \> 150/100 that cannot be ameliorated with standard anti-hypertensives * history of hypertensive crisis or hypertensive encephalopathy * nyha grade ii or \> chf * history of mi within 6 months of enrollment * major surgery, open biopsy, significant trauma within 28 days of enrollment * pregnancy, lactation * abdominal or other fistula, abcess, perforation
transient pseudohypoaldosteronism affecting children with urinary tract malformation

Conditions: Pseudohypoaldosteronism

Summary: pseudohypoaldosteronism is a pathology affecting children under 6 months of age, little known but which can have serious consequences. there are no real figures on the prevalence of this pathology in france. the exact pathophysiology is not known and the management is not currently codified. this is why it is interesting to study this pathology and its treatment on a national scale in order to think about the best possible treatment, as well as to raise awareness of this pathology among different health professionals.


Eligibility criteria:
inclusion criteria: * minor subjects aged less than 6 years at the time of diagnosis * diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between january 1, 2018 and december 31, 2023 * subject (and/or their parental authority) having not expressed, after information, their opposition to the reuse of their data for the purposes of this research. exclusion criteria: * subject (or their parents) having expressed their (their) opposition to participating in the study

Keywords: pseudohypoaldosteronism pseudohypoaldosteronism in children
erythropoietin protects very preterm infants against necrotizing enterocolitis

Conditions: Premature Infant

Summary: this study evaluates the effect of repeated low-dose erythropoietin (epo) treatment on necrotizing enterocolitis (nec) in very preterm infants. half of participants will receive epo, while the other half will receive a placebo.

nec is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. studies have reported that epo treatment decreases the incidence and severity of experimental nec in animal models. evidence from previous clinical studies about the effect of epo treatment against nec have all been hampered by small numbers of patients. the study is to investigate whether repeated low-dose epo protects against nec. preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to epo (500iu/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). primary outcome is the incidence of nec at 36 weeks of corrected age. secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with nec.

Eligibility criteria:
inclusion criteria: * preterm infants with gestation age ≤ 32weeks * within 72 hours after birth * written informed consent obtained from parents exclusion criteria: * genetic or metabolic diseases * congenital abnormalities * polycythemia * intracranial hemorrhage grade iii/iv * unstable vital signs (such as respiration and circulation failure)

Keywords: preterm infant necrotizing enterocolitis erythropoietin neurodevelopment
aim to reduce movements in tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: the purpose of this study is to determine whether an investigational drug, sd-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.


Eligibility criteria:
inclusion criteria: * history of using a dopamine receptor antagonist for at least 3 months * clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening * subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications * have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months * history of being compliant with prescribed medications * able to swallow study drug whole * be in good general health and is expected to attend all study visits and complete study assessments * female subjects must not be pregnant and agree to an acceptable method of contraception exclusion criteria: * currently receiving medication for the treatment of tardive dyskinesia * have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias * have a serious untreated or undertreated psychiatric illness * have recent history or presence of violent behavior * have unstable or serious medical illness * have evidence of hepatic impairment * have evidence of renal impairment * have known allergy to any component of sd-809 or tetrabenazine * has participated in an investigational drug or device trial and received study drug within 30 days * have acknowledged use of illicit drugs * have a history of alcohol or substance abuse in the previous 12 months

Keywords: dyskinesias movement disorders central nervous system diseases nervous system diseases neurologic manifestations signs and symptoms
sars-cov-2 (covid-19) antibody prevalence in an adult london hiv cohort

Conditions: HIV-1-infection; SARS-CoV Infection; Covid19

Summary: prospective, observational sars-cov2 serological surveillance single london hiv outpatient center study using nhs participants

the main aim of this study is to find out how many people living with hiv (plwh) attending a major hiv centre in london, have already been infected with sars-cov2 so far which will be determined through serological blood tests detecting the presence of antibodies to sars-cov2, or have developed antibodies in response to vaccination. however, it is not know whether the presence of antibodies from natural infection means anything more than a marker that someone has been exposed to sars-cov2 previously. it is not know whether this means someone is any less likely to be reinfected in the future or how it will affect possible future infections with sars-cov2. whilst further data on natural and vaccine induced antibody responses is awaited, those with the presence of anti-sars-cov2 antibodies continue to be advised to take the same precautions as everyone else in terms of reducing the risk of getting covid-19: regularly washing hands, wearing a mask and remaining socially distant where possible. now that vaccination has commenced it is also unclear what markers of vaccine induced immunity will develop, including in plwh. this study will help better determine whether hiv should be an additional 'priority' group for vaccination, and also what antibody responses exist in plwh who have been vaccinated the intention is to invite the cohort in for an annual set of hiv related blood tests, covering those who are scheduled for bloods, as well as those who may have missed scheduled blood monitoring appointments during the cov19 lockdown period. in addition to these tests the study proposes offering serological testing for sars cov-2 as part of this surveillance study. participation will be voluntary, and informed consent will be obtained. participants will be informed of their result along with information about the uncertainty of its meaning, beyond indicating previous infection or vaccination. the study aims to test for the presence of specific antibodies that target sars-cov2 in people living with hiv, as a marker of whether someone has been infected before. this will help create a better understanding of whether living with hiv puts people at a higher risk of becoming infected with sars-cov2 compared to the general population, and which other factors or characteristics may affect this risk. this will help identify who might be more at risk of getting covid-19 in the future and will help plan for future covid-19 vaccine strategies.

Eligibility criteria:
inclusion criteria: * documented hiv infection * registered patient at icdc * age ≥18 years at study entry * able to comprehend study patient information leaflet exclusion criteria: * unable to give informed consent and participant without a good understanding of verbal and written english
burden of influenza at emergency department (ed) level in european countries

Conditions: Influenza, Human

Summary: this study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.

study objectives primary: - measure the proportion of non-traumatic emergency department (ed) visits infected with influenza during the peak of the influenza season secondary: * describe the demographic and medical profile of influenza-related and non-influenza-related visits * identify socio-demographic or other risk factors associated with ed visit outcome * describe the influenza positivity rate among ed visits for different causes * measure the proportion of influenza positive patients without classical ili symptoms

Eligibility criteria:
inclusion criteria: * all adult patients seeking care at participating ed during the influenza season * participants and/or guardian providing informed consent and/or assent, as appropriate, to participate. exclusion criteria: * individuals reporting having suffered a traumatic injury without other conditions.

Keywords: emergency room epidemiology
does ivpca increase opioid consumption and side effects in fast track orthopedic procedures?

Conditions: Pain, Postoperative

Summary: the study aims to compare the use of intravenous patient controlled analgesia (ivpca) versus the delivery of pain relief (per oral and intravenous (iv) medications as rescues analgesia) on an as needed basis within a well defined fast track protocol that includes multimodal analgesia for patients who are undergoing elective primary knee replacement surgery. the investigators assumed that with the multimodal analgesia regimen without the use of ivpca will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids related side effects and decreased length of stay in the hospital.


Eligibility criteria:
inclusion criteria: * male or female patients aged 18 to 80 years old * provision of written informed consent * patients scheduled to undergo primary knee surgery included in the fast track protocol under regional anesthesia only * patients with body mass index (bmi) between 18 to 34.9 * patients with american society of anesthesiologists (asa) physical status classification of 1 to 3 exclusion criteria: * patients on chronic (more than twice a week) opioid treatment including tylenol #3, percocet, morphine, methadone, hydromorphone, fentanyl patch and other potent opioids * patients with language barrier or difficulty in communication in english * patients who are allergic to morphine and hydromorphone, fentanyl, gabapentin, celecoxib or acetaminophen * patients with increased risk for respiratory depression with intrathecal morphine (osa, central apnea) * patients with documented renal or hepatic impairment

Keywords: analgesia, patient-controlled analgesics, opioid drug-related side effects and adverse reactions
covid-19 (coronavirus disease-2019) psychiatric outcomes

Conditions: Covid19; Anxiety; Mood; Cognitive Impairment

Summary: the goal of this longitudinal and observational study is to better understand the psychiatric consequences of covid-19 over time. psychiatric outcomes like mood, anxiety, stress, and cognitive symptoms in patients who underwent inpatient hospitalization at newyork-presbyterian hospital/weill cornell medicine for covid-19 will be assessed at 6 months or later post-discharge.


Eligibility criteria:
inclusion criteria-covid-19 group: * men and women age 18-89. * past diagnosis of covid-19 with confirmed positive sars-cov-2 pcr test in electronic medical record * english speaking * previously hospitalized at nyp/wcm between march 1 2020 and six months prior to enrollment for a minimum of three days. inclusion criteria-comparison group: * men and women age 18-89 * english speaking * previously hospitalized at nyp/wcm between march 1 2020 and six months prior to enrollment for a minimum of three days. * underwent hospitalization secondary to a medical diagnosis that was not covid-19 exclusion criteria--covid-19 group: n/a exclusion criteria--comparison group: * past diagnosis of covid-19 * admitted to inpatient hospitalization due to, or past history of, a primary central nervous system relation etiology such as stroke, brain tumor, encephalitis, traumatic brain injury, multiple sclerosis, or parkinson's disease.

Keywords: psychiatric outcome inpatient hospitalization